Serious liver injury induced by Nimesulide: an international collaborative study

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dc.contributor.authorBessone, Fernando
dc.contributor.authorHernandez, Nelia
dc.contributor.authorMendizabal, Manuel
dc.contributor.authorRidruejo, Ezequiel
dc.contributor.authorGualano, Gisela
dc.contributor.authorFassio, Eduardo
dc.contributor.authorPeralta, Mirta
dc.contributor.authorFainboim, Hugo
dc.contributor.authorAnders, Margarita
dc.contributor.authorTanno, Hugo
dc.contributor.authorTanno, Federico
dc.contributor.authorParana, Raymundo
dc.contributor.authorMedina-Caliz, Inmaculada
dc.contributor.authorRobles-Diaz, Mercedes
dc.contributor.authorAlvarez-Alvarez, Ismael
dc.contributor.authorNiu, Hao
dc.contributor.authorStephens, Camilla
dc.contributor.authorColombato, Luis
dc.contributor.authorArrese, Marco
dc.contributor.authorReggiardo, M. Virginia
dc.contributor.authorOno, Suzane Kioko
dc.contributor.authorCarrilho, Flair
dc.contributor.authorLucena, M. Isabel
dc.contributor.authorAndrade, Raul J.
dc.date.accessioned2025-01-20T23:52:12Z
dc.date.available2025-01-20T23:52:12Z
dc.date.issued2021
dc.description.abstractNimesulide is a non-steroidal anti-inflammatory drug still marketed in many countries. We aim to analyze the clinical phenotype, outcome, and histological features of nimesulide-induced liver injury (nimesulide-DILI). We analyzed 57 cases recruited from the Spanish and Latin American DILI registries. Causality was assessed by the RUCAM scale. Mean age of the whole case series was 59 years (86% women) with a median time to onset of 40 days. A total of 46 patients (81%) were jaundiced. Nimesulide-DILI pattern was hepatocellular in 38 (67%), mixed in 12 (21%), and cholestatic in 7 (12%) cases. Transaminases were elevated with a mean of nearly 20-fold the upper limit of normality (ULN), while alkaline phosphatase showed a twofold mean elevation above ULN. Total bilirubin showed a mean elevation of 13-fold the ULN. Liver histology was obtained in 14 cases (25%), most of them with a hepatocellular pattern. Median time to recovery was 60 days. Overall, 12 patients (21%) developed acute liver failure (ALF), five (8.8%) died, three underwent liver transplantation (5.3%), and the remaining four resolved. Latency was <= 15 days in 12 patients (21%) and one patient developed ALF within 7 days from treatment initiation. Increased total bilirubin and aspartate transaminase levels were independently associated with the development of ALF. In summary, nimesulide-DILI affects mainly women and presents typically with a hepatocellular pattern. It is associated with ALF and death in a high proportion of patients. Shorter (<= 15 days) duration of therapy does not prevent serious nimesulide hepatotoxicity, making its risk/benefit ratio clearly unfavorable.
dc.fuente.origenWOS
dc.identifier.doi10.1007/s00204-021-03000-8
dc.identifier.eissn1432-0738
dc.identifier.issn0340-5761
dc.identifier.urihttps://doi.org/10.1007/s00204-021-03000-8
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/94899
dc.identifier.wosidWOS:000631762200001
dc.issue.numero4
dc.language.isoen
dc.pagina.final1487
dc.pagina.inicio1475
dc.revistaArchives of toxicology
dc.rightsacceso restringido
dc.subjectNimesulide
dc.subjectNSAID
dc.subjectHepatotoxicity
dc.subjectAcute liver failure
dc.subjectHepatitis
dc.subjectCholestasis
dc.subject.ods03 Good Health and Well-being
dc.subject.odspa03 Salud y bienestar
dc.titleSerious liver injury induced by Nimesulide: an international collaborative study
dc.typeartículo
dc.volumen95
sipa.indexWOS
sipa.trazabilidadWOS;2025-01-12
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